临床试验常用的英文缩写.doc

1、精品文档专业术语缩略语 英文全称中文全称ADEAdverse Drug Event药物不良事件ADR Adverse Drug Reaction药物不良反应AEAdverse Event不良事件AIAssistant Investigator助理研究者BMI Body Mass Index体质指数CICo-investigator合作研究者COICoordinating Investigator协调研究者CRAClinical Research Associate临床监查员（临床监察员）CRCClinical Research Coordinator临床研究协调者CRFCase Report

2、Form病历报告表CROContract Research Organization合同研究组织CSAClinical Study Application临床研究申请CTAClinical Trial Application临床试验申请CTXClinical Trial Exemption临床试验免责CTPClinical Trial Protocol临床试验方案CTRClinical Trial Report临床试验报告DSMBData Safety and monitoring Board数据安全及监控委员会EDCElectronic Data Capture电子数据采集系统EDP Ele

3、ctronic Data Processing电子数据处理系统FDAFood and Drug Administration美国食品与药品管理局FRFinal Report总结报告GCPGood Clinical Practice药物临床试验质量管理规范GLPGood Laboratory Practice药物非临床试验质量管理规范GMPGood Manufacturing Practice药品生产质量管理规范IBInvestigators Brochure研究者手册ICInformed Consent知情同意ICFInformed Consent Form知情同意书ICHInternatio

4、nal Conference on Harmonization国际协调会议IDMIndependent Data Monitoring独立数据监察IDMCIndependent Data Monitoring Committee独立数据监察委员会IECIndependent Ethics Committee独立伦理委员会INDInvestigational New Drug新药临床研究。1 欢迎下载精品文档IRBInstitutional Review Board机构审查委员会IVDIn Vitro Diagnostic体外诊断IVRSInteractive Voice Response Sy

5、stem互动语音应答系统MAMarketing Approval/Authorization上市许可证MCAMedicines Control Agency英国药品监督局MHW Ministry of Health and Welfare日本卫生福利部NDANew Drug Application新药申请NECNew Drug Entity新化学实体NIHNational Institutes of Health国家卫生研究所（美国）PIPrincipal Investigator主要研究者PLProduct License产品许可证PMAPre-market Approval (Applic

6、ation)上市前许可（申请）PSIStatisticians in the Pharmaceutical Industry制药业统计学家协会QAQuality Assurance质量保证QCQuality Control质量控制RARegulatory Authorities监督管理部门SASite Assessment现场评估SAESerious Adverse Event严重不良事件SAPStatistical Analysis Plan统计分析计划SARSerious Adverse Reaction严重不良反应SDSource Data/Document原始数据 / 文件SDSubj

7、ect Diary受试者日记SFDA State Food and Drug Administration国家食品药品监督管理局SDVSource Data Verification原始数据核准SELSubject Enrollment Log受试者入选表SISub-investigator助理研究者SISponsor-Investigator申办研究者SICSubject Identification Code受试者识别代码SOPStandard Operating Procedure标准操作规程SPLStudy Personnel List研究人员名单SSLSubject Screenin

8、g Log受试者筛选表T&RTest and Reference Product受试和参比试剂UAEUnexpected Adverse Event预料外不良事件WHO World Health Organization世界卫生组织WHO-ICDRAWHO International Conference of Drug Regulatory AuthoritiesWHO国际药品管理当局会议Active Control阳性对照、活性对照。2 欢迎下载精品文档Audit稽查Audit Report稽查报告Auditor稽查员Blank Control空白对照Blinding/masking盲法

9、/设盲Case History病历Clinical study临床研究Clinical Trial临床试验Clinical Trial Report临床试验报告Compliance依从性Coordinating Committee协调委员会Cross-over Study交叉研究Double Blinding双盲Endpoint Criteria/measurement终点指标Essential Documentation必需文件Exclusion Criteria排除标准Inclusion Criteria入选表准Information Gathering信息收集Initial Meetin

10、g启动会议Inspection检察 /视察Institution Inspection机构检察Investigational Product试验药物Investigator研究者Monitor监查员（监察员）Monitoring监查（监察）Monitoring Plan监查计划（监察计划）Monitoring Report监查报告（监察报告）Multi-center Trial多中心试验Non-clinical Study非临床研究Original Medical Record原始医疗记录Outcome Assessment结果评价Patient File病人档案Patient History

11、病历Placebo安慰剂Placebo Control安慰剂对照Preclinical Study临床前研究Protocol试验方案Protocol Amendments修正案。3 欢迎下载精品文档Randomization随机Reference Product参比制剂Sample Size样本量、样本大小Seriousness严重性Severity严重程度Single Blinding单盲Sponsor申办者Study Audit研究稽查Subject受试者Subject Enrollment受试者入选Subject Enrollment Log受试者入选表Subject Identification Code List受试者识别代码表Subject Recruitment受试者招募Study Site研究中心Subject Screening Log受试者筛选表System Audit系统稽查Test Product受试制剂Tri